Signatera Genome demonstrated 100% sensitivity and specificity in detecting breast cancer recurrence in the surveillance setting

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that at least twelve abstracts highlighting Signatera will be shared at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12.

The presentations encompass aggregated data from more than 50,000 patients in real-world evidence and prospective clinical studies, demonstrating the prognostic and predictive power of Signatera across diverse breast cancer subtypes and settings. These include real-world studies of Signatera adoption and clinical impact at Yale, Houston Methodist and other leading institutions. Additional highlights include:

Signatera Genome study

In a real-world cohort of 227 patients with triple-negative, HR+/HER2- and HER2+ breast cancers, during surveillance Signatera Genome detected recurrence with a sensitivity and specificity of 100%.

• Patients who were Signatera-positive within 3 months of surgery were at a significantly higher risk of distant disease recurrence (HR: 13.1, 95% CI: 1.4-122.1, P = 0.005).
• Signatera positivity at any time post-definitive treatment was associated with significantly worse distant recurrence-free survival (HR: 221.2, 95% CI: 131.0-373.4, P <0.0001).

LEADER trial

This phase 2 randomized study aims to evaluate the efficacy of adding the CDK4/6 inhibitor, ribociclib, to adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer who test Signatera-positive during surveillance.

• Patients with sustained MRD negativity remained disease-free during extended followup (12−month NPV: RFS=99%, DRFS=100%).
• MRD-positive patients initiating ribociclib achieved high rates of ctDNA decrease or clearance, translating to delayed onset of distant recurrence (18.6 vs 5.4 from treatment start).

“We are proud to share our largest dataset for SABCS thus far, featuring the value of Signatera in risk stratification, the early detection of molecular relapse and treatment response monitoring,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The findings from these prospective clinical studies and real-world evidence add important context on how Signatera can provide personalized insights and optimize treatment across all breast cancer subtypes and indications, and the new data with Signatera Genome offer even greater promise for MRD testing.”

The full list of presentations at SABCS includes:

December 10, 4:30 PM CT | RF3-04 (Oral Presentation)

Presenter: Heather A. Parsons

Tumor-informed circulating tumor DNA analysis to assess molecular residual disease for prognosis and prediction of benefit from palbociclib in the PALLAS trial

December 10, 5:00 PM CT | PS2-09-04

Presenter: Julia Foldi

Predicting outcomes for patients with mixed ductal/lobular carcinoma of the breast based on circulating tumor DNA positivity patterns

December 10, 5:00 PM CT | PS2-10-03

Presenter: Devora Isserfoff

Impact of Circulating Tumor DNA (ctDNA) monitoring on Patient Anxiety and Clinician Decision-Making in Early-Stage Breast Cancer (PACE-ctDNA)

December 10, 5:00 PM CT | PS2-08-21

Presenter: Amy J. Xu

Circulating tumor DNA (ctDNA) Dynamics in Early-stage Breast Cancer Patients (pts) with Brain Metastases

December 10, 5:00 PM CT | PS2-08-12

Presenter: Julia Foldi

Age-associated divergence in breast cancer: clinical, molecular, and genomic insights from a large real-world cohort

December 10, 5:00 PM CT | PS2-09-20

Presenter: Daniel Stover

Circulating Tumor DNA Dynamics and Anatomical Patterns of Relapse Following Curative Therapy in Early-Stage Breast Cancer

December 10, 5:00 PM CT | PS2-07-26

Presenter: Wassim McHayleh

Clinical performance of Signatera Genome assay for predicting recurrence in patients with breast cancer

December 11, 7:00 AM CT | PD6-07 (Poster Spotlight)

Presenter: Mark Jesus Magbanua

ctDNA dynamics is most predictive of response in treatment-sensitive response-predictive subtypes of breast cancer: Results from the I-SPY2 trial

December 11, 7:00 AM CT | PD5-01 (Poster Spotlight)

Presenter: Arielle J. Medford

Personalized circulating tumor DNA (ctDNA) testing, intervention, and temporal dynamics in ER+/HER2- early-stage breast cancer (LEADER)

December 11, 7:00 AM CT | PD9-01 (Poster Spotlight)

Presenter: Steffi Oesterreich

Comprehensive Genomic Landscape of Invasive Lobular Carcinoma Reveals Distinct Molecular Subtypes

December 11, 12:30 PM CT | PS3-01-05

Presenter: Banu Arun

Prevalence and Characterization of Germline CDH1 Mutations in a Large Real-World Breast Cancer Cohort

December 11, 5:00 PM CT | PS4-02-25

Presenter: Minhal Zaidi

Single Institution experience of longitudinal post-surgical circulating tumor DNA monitoring in patients with HER2+ breast cancer

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 325 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

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